All-in-one Software Solution and Expert Consulting for Medical Device and Drug Combination Product Design Controls, Risk Management, Cybersecurity, Safety and Compliance Assurance Cases
QMSpace™ Design Controls: All in One Solution for Design Controls
- Intuitive traceability among needs, requirements, specifications, test cases results
- Tabular, graphic and narrative editors, and Export to html, word or PDF
- Automatic linking to risk management and safety assurance cases
- Design History File (DHF) Management (Plans, Reports etc.)
- Life cycle change management
QMSpace™ Risk Management: All in One Global Risk Management Solution
- All in one Electronic Risk Management File in compliance with standards and regulations (e.g. ISO 14971, ISO 13485 and FDA requirements)
- Support multiple risks (safety, performance, cybersecurity, business etc.) and multiple sets (for different business units, product lines etc.)
- Highly configurable Templates for Hazard Analysis / Risk Assessment, Failure Mode and Effects Analysis (dFMEA, uFMEA and pFMEA) with results automatically linked
- Built-in toolkit for Fault Tree Analysis (FTA) with reliability calculation and automatic linking with the risk analysis results
- Multi Analytical Reports - Risk Heat Map, Interaction Maps, Checklists etc.
- Part 11 Compliant Electronic records and signatures
- Plug ins and APIs for connectivity with other requirement management tools
QMSpace™ Cybersecurity: All in One Global Cybersecurity Risk Management Solution
- All in one Electronic Cybersecurity Risk Management File in compliance with standards and regulations
- Highly configurable Templates for Asset Profiling, Threat Modeling / Attack Tree Analysis, Vulnerability Analysis, Security Control Measures, Cybersecurity Risk Assessment and Summary etc.
- Automatic connectivity with Safety Risk Management
- Multi Analytical Reports - Risk Heat Map, Standard based Checklists etc.
- Part 11 Compliant Electronic records and signatures
- Life Cycle Cybersecurity Risk Management
QMSpace™ Assurance Cases: All in One Assurance Case Development Solution
- Tabular, graphic, and narractive safety assurance case editors
- Able to convert the tabular or XML format safety assurance case into graphic HTML file that can be viewed and navigated using a web browser
- Able to convert existing risk management information into a safety assurance case table or graphic
- Integration of risk management and safety assurance case throughout the product life cycle
- Intuitively guiding for additional information that is needed for a robust safety assurance case
- Electronic submission of safety assurance cases to the FDA